IBD & Intestinal Disorders

CHICAGO – Medications to treat inflammatory bowel disease were well tolerated in pregnancy and weren’t linked to worse maternal-fetal outcomes, according to a study of more than 1,000 pregnant women.

Despite many physicians’ concerns about the safety of azathioprine and biologic agents during pregnancy, maternal exposure to those IBD medications was not associated with an increase in adverse outcomes such as preterm birth or congenital anomalies, explained Dr. Uma Mahadevan of the University of California, San Francisco Center for Colitis and Crohn’s Disease.

"If you continue [the medications] and control your disease and have a healthy pregnancy, that’s the key to having a healthy baby," Dr. Mahadevan observed.

In a video interview at the annual Digestive Disease Week, Dr. Mahadevan discussed the study’s findings, whether combination therapy has an impact on the risk of preterm birth, and what effect IBD medication exposure may have had on children’s achievement of developmental milestones up to age 4 years.

pwendling@frontlinemedcom.com

CHICAGO – Medications to treat inflammatory bowel disease were well tolerated in pregnancy and weren’t linked to worse maternal-fetal outcomes, according to a study of more than 1,000 pregnant women.

Despite many physicians’ concerns about the safety of azathioprine and biologic agents during pregnancy, maternal exposure to those IBD medications was not associated with an increase in adverse outcomes such as preterm birth or congenital anomalies, explained Dr. Uma Mahadevan of the University of California, San Francisco Center for Colitis and Crohn’s Disease.

"If you continue [the medications] and control your disease and have a healthy pregnancy, that’s the key to having a healthy baby," Dr. Mahadevan observed.

In a video interview at the annual Digestive Disease Week, Dr. Mahadevan discussed the study’s findings, whether combination therapy has an impact on the risk of preterm birth, and what effect IBD medication exposure may have had on children’s achievement of developmental milestones up to age 4 years.

pwendling@frontlinemedcom.com

CHICAGO – Medications to treat inflammatory bowel disease were well tolerated in pregnancy and weren’t linked to worse maternal-fetal outcomes, according to a study of more than 1,000 pregnant women.

Despite many physicians’ concerns about the safety of azathioprine and biologic agents during pregnancy, maternal exposure to those IBD medications was not associated with an increase in adverse outcomes such as preterm birth or congenital anomalies, explained Dr. Uma Mahadevan of the University of California, San Francisco Center for Colitis and Crohn’s Disease.

"If you continue [the medications] and control your disease and have a healthy pregnancy, that’s the key to having a healthy baby," Dr. Mahadevan observed.

In a video interview at the annual Digestive Disease Week, Dr. Mahadevan discussed the study’s findings, whether combination therapy has an impact on the risk of preterm birth, and what effect IBD medication exposure may have had on children’s achievement of developmental milestones up to age 4 years.

pwendling@frontlinemedcom.com

CHICAGO – Patients with hypothyroidism who needed higher doses of levothyroxine were more likely to have celiac disease, according to a study released at the annual Digestive Disease Week.

In a study of 400 patients with hypothyroidism, about 5% of those who needed at least 125 mcg/day of levothyroxine also had celiac disease, according to Dr. Richard Zubarik of the University of Vermont, Burlington.That prevalence rate tops even the rate among patients with iron deficiency anemia, for whom celiac disease screening is recommended.

In a video interview, Dr. Zubarik explains which patients with hypothyroidism should be screened for celiac disease, and he discusses what mechanisms might link the need for higher levels of levothyroxine with an increased risk of celiac disease.

bjancin@frontlinemedcom.com

CHICAGO – Patients with hypothyroidism who needed higher doses of levothyroxine were more likely to have celiac disease, according to a study released at the annual Digestive Disease Week.

In a study of 400 patients with hypothyroidism, about 5% of those who needed at least 125 mcg/day of levothyroxine also had celiac disease, according to Dr. Richard Zubarik of the University of Vermont, Burlington.That prevalence rate tops even the rate among patients with iron deficiency anemia, for whom celiac disease screening is recommended.

In a video interview, Dr. Zubarik explains which patients with hypothyroidism should be screened for celiac disease, and he discusses what mechanisms might link the need for higher levels of levothyroxine with an increased risk of celiac disease.

bjancin@frontlinemedcom.com

CHICAGO – Patients with hypothyroidism who needed higher doses of levothyroxine were more likely to have celiac disease, according to a study released at the annual Digestive Disease Week.

In a study of 400 patients with hypothyroidism, about 5% of those who needed at least 125 mcg/day of levothyroxine also had celiac disease, according to Dr. Richard Zubarik of the University of Vermont, Burlington.That prevalence rate tops even the rate among patients with iron deficiency anemia, for whom celiac disease screening is recommended.

In a video interview, Dr. Zubarik explains which patients with hypothyroidism should be screened for celiac disease, and he discusses what mechanisms might link the need for higher levels of levothyroxine with an increased risk of celiac disease.

bjancin@frontlinemedcom.com

CHICAGO – A diet that restricts wheat, beans, dairy, and fruit juice in children with irritable bowel syndrome reduced the frequency and severity of abdominal pain, according to a study presented at the annual Digestive Disease Week.

In a double-blind, randomized, crossover trial of 55 children, those who followed a low FODMAP (fermentable oligo-di-monosaccharides and polyols) diet decreased abdominal pain frequency 20%-30%, explained Dr. Bruno Chumpitazi of Texas Children’s Hospital, Houston.

In a video interview, Dr. Chumpitazi discusses the study's implications for the nearly 20% of school-age children and adolescents who may have IBS, and whether the low FODMAP diet could be a first-line therapy for those children.

bjancin@frontlinemedcom.com

CHICAGO – A diet that restricts wheat, beans, dairy, and fruit juice in children with irritable bowel syndrome reduced the frequency and severity of abdominal pain, according to a study presented at the annual Digestive Disease Week.

In a double-blind, randomized, crossover trial of 55 children, those who followed a low FODMAP (fermentable oligo-di-monosaccharides and polyols) diet decreased abdominal pain frequency 20%-30%, explained Dr. Bruno Chumpitazi of Texas Children’s Hospital, Houston.

In a video interview, Dr. Chumpitazi discusses the study's implications for the nearly 20% of school-age children and adolescents who may have IBS, and whether the low FODMAP diet could be a first-line therapy for those children.

bjancin@frontlinemedcom.com

CHICAGO – A diet that restricts wheat, beans, dairy, and fruit juice in children with irritable bowel syndrome reduced the frequency and severity of abdominal pain, according to a study presented at the annual Digestive Disease Week.

In a double-blind, randomized, crossover trial of 55 children, those who followed a low FODMAP (fermentable oligo-di-monosaccharides and polyols) diet decreased abdominal pain frequency 20%-30%, explained Dr. Bruno Chumpitazi of Texas Children’s Hospital, Houston.

In a video interview, Dr. Chumpitazi discusses the study's implications for the nearly 20% of school-age children and adolescents who may have IBS, and whether the low FODMAP diet could be a first-line therapy for those children.

bjancin@frontlinemedcom.com

Oral budesonide is effective and safe for short-term treatment of collagenous colitis.

Indeed, the finding supports the recent recommendation by the European Microscopic Colitis Group to make budesonide the "treatment of choice for active microscopic colitis," wrote Dr. Stephan Miehlke and colleagues in the May 1 issue of Gastroenterology (doi:10.1053/j.gastro.2014.01.019).

In a phase III study sponsored by the maker of budesonide, Dr. Miehlke of the Center for Digestive Diseases Eppendorf, in Hamburg, Germany, looked at 92 adult patients with histologically confirmed collagenous colitis.

Patients hailed from 31 international centers, and in addition to histology all also met the following criteria: more than four watery or soft stools on at least 4 days in the week before baseline; greater than three stools per day on average within the last 7 days before baseline; chronic diarrhea for at least 3 months; and a history of colonoscopy within 1 year of baseline.

For inclusion in the study, antidiarrheal medications had to have been discontinued by 2 weeks before baseline, and no other gastrointestinal comorbidities were permitted, such as Crohn’s disease or ulcerative colitis.

Patients were then assigned to one of three treatment groups: budesonide 9 mg once daily; mesalamine 3 g daily; or placebo.

Clinical remission was defined as having fewer than three stools per day in the week before the visit

At the end of the 8-week double-blind study period, the investigators found that budesonide significantly reduced the mean number of watery stools per week from 29.7 to 2.4 (P less than.0001) and increased the mean number of solid stools per week from 0.3 to 6.7 (P less than.0001).

This corresponded with a Kaplan-Meier analysis revealing that the time to clinical remission was significantly shorter for patients taking budesonide (median 7 days), compared with placebo (median 21 days; P =.0144) or mesalamine (median 24 days; P =.0071).

Dr. Miehlke also obtained follow-up biopsies on 63 patients at the 8-week mark, including 23 budesonide patients, 18 taking mesalamine, and 22 placebo patients.

Ultimately, 87% of budesonide patients had histologic posttreatment remission, versus 50% of placebo patients (P =.0106) and 45% of mesalamine patients.

Looking at safety, while the authors reported that the rates of adverse events were similar between cohorts, none of the adverse events in the budesonide group were considered drug related.

The most frequent adverse events in all groups included headache, nasopharyngitis, and dyspepsia.

Dr. Miehlke postulated several possible reasons for budesonide’s efficacy in the microscopic colitis cohort.

"First, it exerts a well-documented and potent anti-inflammatory effect in the terminal ileum and right colon, as clearly shown in Crohn’s disease," he wrote.

"In addition, budesonide improves bile acid malabsorption, which might occur in a substantial number of patients with microscopic colitis, by up-regulating the bile acid transporter gene expression in the small bowel."

Finally, "there is evidence that budesonide improves the small intestine’s water-absorption capacity, lowering the ileostomy output in quiescent Crohn’s disease," he concluded.

The investigators disclosed that the study was sponsored by Dr Falk Pharma GmbH, the maker of budesonide. Dr. Miehlke and several coinvestigators also disclosed financial relationships with Dr Falk Pharma GmbH; two others are employees of the company.

Oral budesonide is effective and safe for short-term treatment of collagenous colitis.

Indeed, the finding supports the recent recommendation by the European Microscopic Colitis Group to make budesonide the "treatment of choice for active microscopic colitis," wrote Dr. Stephan Miehlke and colleagues in the May 1 issue of Gastroenterology (doi:10.1053/j.gastro.2014.01.019).

In a phase III study sponsored by the maker of budesonide, Dr. Miehlke of the Center for Digestive Diseases Eppendorf, in Hamburg, Germany, looked at 92 adult patients with histologically confirmed collagenous colitis.

Patients hailed from 31 international centers, and in addition to histology all also met the following criteria: more than four watery or soft stools on at least 4 days in the week before baseline; greater than three stools per day on average within the last 7 days before baseline; chronic diarrhea for at least 3 months; and a history of colonoscopy within 1 year of baseline.

For inclusion in the study, antidiarrheal medications had to have been discontinued by 2 weeks before baseline, and no other gastrointestinal comorbidities were permitted, such as Crohn’s disease or ulcerative colitis.

Patients were then assigned to one of three treatment groups: budesonide 9 mg once daily; mesalamine 3 g daily; or placebo.

Clinical remission was defined as having fewer than three stools per day in the week before the visit

At the end of the 8-week double-blind study period, the investigators found that budesonide significantly reduced the mean number of watery stools per week from 29.7 to 2.4 (P less than.0001) and increased the mean number of solid stools per week from 0.3 to 6.7 (P less than.0001).

This corresponded with a Kaplan-Meier analysis revealing that the time to clinical remission was significantly shorter for patients taking budesonide (median 7 days), compared with placebo (median 21 days; P =.0144) or mesalamine (median 24 days; P =.0071).

Dr. Miehlke also obtained follow-up biopsies on 63 patients at the 8-week mark, including 23 budesonide patients, 18 taking mesalamine, and 22 placebo patients.

Ultimately, 87% of budesonide patients had histologic posttreatment remission, versus 50% of placebo patients (P =.0106) and 45% of mesalamine patients.

Looking at safety, while the authors reported that the rates of adverse events were similar between cohorts, none of the adverse events in the budesonide group were considered drug related.

The most frequent adverse events in all groups included headache, nasopharyngitis, and dyspepsia.

Dr. Miehlke postulated several possible reasons for budesonide’s efficacy in the microscopic colitis cohort.

"First, it exerts a well-documented and potent anti-inflammatory effect in the terminal ileum and right colon, as clearly shown in Crohn’s disease," he wrote.

"In addition, budesonide improves bile acid malabsorption, which might occur in a substantial number of patients with microscopic colitis, by up-regulating the bile acid transporter gene expression in the small bowel."

Finally, "there is evidence that budesonide improves the small intestine’s water-absorption capacity, lowering the ileostomy output in quiescent Crohn’s disease," he concluded.

The investigators disclosed that the study was sponsored by Dr Falk Pharma GmbH, the maker of budesonide. Dr. Miehlke and several coinvestigators also disclosed financial relationships with Dr Falk Pharma GmbH; two others are employees of the company.

Oral budesonide is effective and safe for short-term treatment of collagenous colitis.

Indeed, the finding supports the recent recommendation by the European Microscopic Colitis Group to make budesonide the "treatment of choice for active microscopic colitis," wrote Dr. Stephan Miehlke and colleagues in the May 1 issue of Gastroenterology (doi:10.1053/j.gastro.2014.01.019).

In a phase III study sponsored by the maker of budesonide, Dr. Miehlke of the Center for Digestive Diseases Eppendorf, in Hamburg, Germany, looked at 92 adult patients with histologically confirmed collagenous colitis.

Patients hailed from 31 international centers, and in addition to histology all also met the following criteria: more than four watery or soft stools on at least 4 days in the week before baseline; greater than three stools per day on average within the last 7 days before baseline; chronic diarrhea for at least 3 months; and a history of colonoscopy within 1 year of baseline.

For inclusion in the study, antidiarrheal medications had to have been discontinued by 2 weeks before baseline, and no other gastrointestinal comorbidities were permitted, such as Crohn’s disease or ulcerative colitis.

Patients were then assigned to one of three treatment groups: budesonide 9 mg once daily; mesalamine 3 g daily; or placebo.

Clinical remission was defined as having fewer than three stools per day in the week before the visit

At the end of the 8-week double-blind study period, the investigators found that budesonide significantly reduced the mean number of watery stools per week from 29.7 to 2.4 (P less than.0001) and increased the mean number of solid stools per week from 0.3 to 6.7 (P less than.0001).

This corresponded with a Kaplan-Meier analysis revealing that the time to clinical remission was significantly shorter for patients taking budesonide (median 7 days), compared with placebo (median 21 days; P =.0144) or mesalamine (median 24 days; P =.0071).

Dr. Miehlke also obtained follow-up biopsies on 63 patients at the 8-week mark, including 23 budesonide patients, 18 taking mesalamine, and 22 placebo patients.

Ultimately, 87% of budesonide patients had histologic posttreatment remission, versus 50% of placebo patients (P =.0106) and 45% of mesalamine patients.

Looking at safety, while the authors reported that the rates of adverse events were similar between cohorts, none of the adverse events in the budesonide group were considered drug related.

The most frequent adverse events in all groups included headache, nasopharyngitis, and dyspepsia.

Dr. Miehlke postulated several possible reasons for budesonide’s efficacy in the microscopic colitis cohort.

"First, it exerts a well-documented and potent anti-inflammatory effect in the terminal ileum and right colon, as clearly shown in Crohn’s disease," he wrote.

"In addition, budesonide improves bile acid malabsorption, which might occur in a substantial number of patients with microscopic colitis, by up-regulating the bile acid transporter gene expression in the small bowel."

Finally, "there is evidence that budesonide improves the small intestine’s water-absorption capacity, lowering the ileostomy output in quiescent Crohn’s disease," he concluded.

The investigators disclosed that the study was sponsored by Dr Falk Pharma GmbH, the maker of budesonide. Dr. Miehlke and several coinvestigators also disclosed financial relationships with Dr Falk Pharma GmbH; two others are employees of the company.

There is no significant difference between infliximab and adalimumab in Crohn’s disease, reported Dr. Mark T. Osterman and his colleagues in the May 1 issue of Clinical Gastroenterology and Hepatology (doi:10.1016/j.cgh.2013.06.010).

Indeed, in a study that they called "one of the first to directly compare the effectiveness of these two therapies for CD [Crohn’s disease]," the researchers calculated that rates of hospitalization and surgery while on these therapies were statistically similar, providing "justification for allowing patients’ preferences to be a major factor when choosing between these two medications."

Dr. Osterman of the department of medicine at the University of Pennsylvania, Philadelphia, and his colleagues conducted a retrospective cohort analysis of Medicare data on new users of the either adalimumab or infliximab between 2006 and 2010.

Participants had no history of using any anti–tumor necrosis factor (TNF) medications before the index prescription, as well as a diagnosis of Crohn’s in the 12 months prior.

Exclusion criteria included age greater than 85 years on the index anti-TNF prescription date; a coexisting diagnosis of rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis; or a diagnosis of ulcerative colitis on or immediately preceding the index date.

In total, the authors analyzed data on 1,445 infliximab patients and 865 adalimumab patients, more than 60% of whom were female and more than 90% of whom were white.

First, the authors assessed the persistence of each drug. They found that after 26 weeks of therapy, 49% of infliximab patients were still taking the drug, as were 47% of adalimumab users (adjusted odds ratio, 0.98; 95% confidence interval 0.81-1.19).

Similarly, by 1 year, the rates of persistence were 31% and 28% for infliximab and adalimumab, respectively (adjusted OR, 1.08; 95% CI, 0.86-1.37).

Next, the authors analyzed surgery-related outcomes. They found that although infliximab patients had a numerically lower incidence of surgery (including bowel resection, ostomy creation, or treatment of a perforation or abscess), the difference did not reach statistical significance (5.5 vs. 6.9 surgeries per 100 person-years, respectively; adjusted hazard ratio, 0.79; 95% CI, 0.60-1.05).

The final outcome assessed was the rate of hospitalizations attributed to Crohn’s disease. Here, too, Dr. Osterman found no significant difference between infliximab (11.8/100 patient-years) and adalimumab patients (15.4/100 patient-years) (adjusted HR, 0.88; 95% CI, 0.72-1.07).

The researchers did concede several limitations, including the fact that they did not compare adverse event rates in their analysis, although they stated that, "In general, the safety profiles of infliximab and adalimumab are believed to be similar with a few exceptions."

Dr. Osterman also wrote that the observational nature of the present analysis is by definition less robust than a head-to-head clinical trial; however, given the extreme cost of such studies, such potentially more definitive analyses "are unlikely to ever be undertaken."

Nevertheless, the current retrospective study should "allow patients, physicians, and insurers to develop rational treatment strategies and guidelines" in the treatment of CD.

Dr. Osterman and several of his coauthors disclosed financial relationships with pharmaceutical companies, including the makers of infliximab and adalimumab, Janssen Biotech and AbbVie, respectively. The researchers disclosed grant funding for this study from the Agency for Healthcare Research and Quality and the National Institutes of Health.

There is no significant difference between infliximab and adalimumab in Crohn’s disease, reported Dr. Mark T. Osterman and his colleagues in the May 1 issue of Clinical Gastroenterology and Hepatology (doi:10.1016/j.cgh.2013.06.010).

Indeed, in a study that they called "one of the first to directly compare the effectiveness of these two therapies for CD [Crohn’s disease]," the researchers calculated that rates of hospitalization and surgery while on these therapies were statistically similar, providing "justification for allowing patients’ preferences to be a major factor when choosing between these two medications."

Dr. Osterman of the department of medicine at the University of Pennsylvania, Philadelphia, and his colleagues conducted a retrospective cohort analysis of Medicare data on new users of the either adalimumab or infliximab between 2006 and 2010.

Participants had no history of using any anti–tumor necrosis factor (TNF) medications before the index prescription, as well as a diagnosis of Crohn’s in the 12 months prior.

Exclusion criteria included age greater than 85 years on the index anti-TNF prescription date; a coexisting diagnosis of rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis; or a diagnosis of ulcerative colitis on or immediately preceding the index date.

In total, the authors analyzed data on 1,445 infliximab patients and 865 adalimumab patients, more than 60% of whom were female and more than 90% of whom were white.

First, the authors assessed the persistence of each drug. They found that after 26 weeks of therapy, 49% of infliximab patients were still taking the drug, as were 47% of adalimumab users (adjusted odds ratio, 0.98; 95% confidence interval 0.81-1.19).

Similarly, by 1 year, the rates of persistence were 31% and 28% for infliximab and adalimumab, respectively (adjusted OR, 1.08; 95% CI, 0.86-1.37).

Next, the authors analyzed surgery-related outcomes. They found that although infliximab patients had a numerically lower incidence of surgery (including bowel resection, ostomy creation, or treatment of a perforation or abscess), the difference did not reach statistical significance (5.5 vs. 6.9 surgeries per 100 person-years, respectively; adjusted hazard ratio, 0.79; 95% CI, 0.60-1.05).

The final outcome assessed was the rate of hospitalizations attributed to Crohn’s disease. Here, too, Dr. Osterman found no significant difference between infliximab (11.8/100 patient-years) and adalimumab patients (15.4/100 patient-years) (adjusted HR, 0.88; 95% CI, 0.72-1.07).

The researchers did concede several limitations, including the fact that they did not compare adverse event rates in their analysis, although they stated that, "In general, the safety profiles of infliximab and adalimumab are believed to be similar with a few exceptions."

Dr. Osterman also wrote that the observational nature of the present analysis is by definition less robust than a head-to-head clinical trial; however, given the extreme cost of such studies, such potentially more definitive analyses "are unlikely to ever be undertaken."

Nevertheless, the current retrospective study should "allow patients, physicians, and insurers to develop rational treatment strategies and guidelines" in the treatment of CD.

Dr. Osterman and several of his coauthors disclosed financial relationships with pharmaceutical companies, including the makers of infliximab and adalimumab, Janssen Biotech and AbbVie, respectively. The researchers disclosed grant funding for this study from the Agency for Healthcare Research and Quality and the National Institutes of Health.

There is no significant difference between infliximab and adalimumab in Crohn’s disease, reported Dr. Mark T. Osterman and his colleagues in the May 1 issue of Clinical Gastroenterology and Hepatology (doi:10.1016/j.cgh.2013.06.010).

Indeed, in a study that they called "one of the first to directly compare the effectiveness of these two therapies for CD [Crohn’s disease]," the researchers calculated that rates of hospitalization and surgery while on these therapies were statistically similar, providing "justification for allowing patients’ preferences to be a major factor when choosing between these two medications."

Dr. Osterman of the department of medicine at the University of Pennsylvania, Philadelphia, and his colleagues conducted a retrospective cohort analysis of Medicare data on new users of the either adalimumab or infliximab between 2006 and 2010.

Participants had no history of using any anti–tumor necrosis factor (TNF) medications before the index prescription, as well as a diagnosis of Crohn’s in the 12 months prior.

Exclusion criteria included age greater than 85 years on the index anti-TNF prescription date; a coexisting diagnosis of rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis; or a diagnosis of ulcerative colitis on or immediately preceding the index date.

In total, the authors analyzed data on 1,445 infliximab patients and 865 adalimumab patients, more than 60% of whom were female and more than 90% of whom were white.

First, the authors assessed the persistence of each drug. They found that after 26 weeks of therapy, 49% of infliximab patients were still taking the drug, as were 47% of adalimumab users (adjusted odds ratio, 0.98; 95% confidence interval 0.81-1.19).

Similarly, by 1 year, the rates of persistence were 31% and 28% for infliximab and adalimumab, respectively (adjusted OR, 1.08; 95% CI, 0.86-1.37).

Next, the authors analyzed surgery-related outcomes. They found that although infliximab patients had a numerically lower incidence of surgery (including bowel resection, ostomy creation, or treatment of a perforation or abscess), the difference did not reach statistical significance (5.5 vs. 6.9 surgeries per 100 person-years, respectively; adjusted hazard ratio, 0.79; 95% CI, 0.60-1.05).

The final outcome assessed was the rate of hospitalizations attributed to Crohn’s disease. Here, too, Dr. Osterman found no significant difference between infliximab (11.8/100 patient-years) and adalimumab patients (15.4/100 patient-years) (adjusted HR, 0.88; 95% CI, 0.72-1.07).

The researchers did concede several limitations, including the fact that they did not compare adverse event rates in their analysis, although they stated that, "In general, the safety profiles of infliximab and adalimumab are believed to be similar with a few exceptions."

Dr. Osterman also wrote that the observational nature of the present analysis is by definition less robust than a head-to-head clinical trial; however, given the extreme cost of such studies, such potentially more definitive analyses "are unlikely to ever be undertaken."

Nevertheless, the current retrospective study should "allow patients, physicians, and insurers to develop rational treatment strategies and guidelines" in the treatment of CD.

Dr. Osterman and several of his coauthors disclosed financial relationships with pharmaceutical companies, including the makers of infliximab and adalimumab, Janssen Biotech and AbbVie, respectively. The researchers disclosed grant funding for this study from the Agency for Healthcare Research and Quality and the National Institutes of Health.

The prevalence of celiac disease is four times higher among children who have irritable bowel syndrome than in the general population of children, according to a report published online April 21 in JAMA Pediatrics.

Celiac disease was recently shown to occur approximately four times more often in adults with IBS than in the general population, but the prevalence in the pediatric population has not been assessed.

Researchers in Italy performed a prospective observational cohort study involving all 992 children aged 4-16 years who were referred to a single university hospital for recurrent abdominal pain during a 6-year period. About 43% of the children were boys. The median age was 6.8 years.

A total of 270 children were found to have irritable bowel syndrome. Fifteen of them also tested positive for serum IgA antitissue transglutaminase and endomysial antibodies, and all 15 also proved to have mucosal atrophy on duodenal biopsy specimens, which is indicative of celiac disease, said Dr. Fernanda Cristofori of the University of Bari (Italy) and Giovanni XXIII Hospital.

Thus, the prevalence of celiac disease was 4.4% in the children who had IBS. In comparison, the highest prevalence of celiac disease in any Italian population of children assessed to date was 1.1% in a study of 3,188 school children, the investigators said (JAMA Ped. 2014 April 21 [doi:10.1001/jamapediatrics.2013.4984]).

Clinicians should consider screening their IBS patients for celiac disease, given that 1 in 23 children with IBS in this series proved to have concomitant celiac disease. Failing to diagnose celiac disease in childhood increases the risk of complications such as osteopenia, short stature, delayed puberty, infertility, and intestinal lymphoma in late adulthood, Dr. Cristofori and her associates noted.

They reported no financial conflicts of interest.

The prevalence of celiac disease is four times higher among children who have irritable bowel syndrome than in the general population of children, according to a report published online April 21 in JAMA Pediatrics.

Celiac disease was recently shown to occur approximately four times more often in adults with IBS than in the general population, but the prevalence in the pediatric population has not been assessed.

Researchers in Italy performed a prospective observational cohort study involving all 992 children aged 4-16 years who were referred to a single university hospital for recurrent abdominal pain during a 6-year period. About 43% of the children were boys. The median age was 6.8 years.

A total of 270 children were found to have irritable bowel syndrome. Fifteen of them also tested positive for serum IgA antitissue transglutaminase and endomysial antibodies, and all 15 also proved to have mucosal atrophy on duodenal biopsy specimens, which is indicative of celiac disease, said Dr. Fernanda Cristofori of the University of Bari (Italy) and Giovanni XXIII Hospital.

Thus, the prevalence of celiac disease was 4.4% in the children who had IBS. In comparison, the highest prevalence of celiac disease in any Italian population of children assessed to date was 1.1% in a study of 3,188 school children, the investigators said (JAMA Ped. 2014 April 21 [doi:10.1001/jamapediatrics.2013.4984]).

Clinicians should consider screening their IBS patients for celiac disease, given that 1 in 23 children with IBS in this series proved to have concomitant celiac disease. Failing to diagnose celiac disease in childhood increases the risk of complications such as osteopenia, short stature, delayed puberty, infertility, and intestinal lymphoma in late adulthood, Dr. Cristofori and her associates noted.

They reported no financial conflicts of interest.

The prevalence of celiac disease is four times higher among children who have irritable bowel syndrome than in the general population of children, according to a report published online April 21 in JAMA Pediatrics.

Celiac disease was recently shown to occur approximately four times more often in adults with IBS than in the general population, but the prevalence in the pediatric population has not been assessed.

Researchers in Italy performed a prospective observational cohort study involving all 992 children aged 4-16 years who were referred to a single university hospital for recurrent abdominal pain during a 6-year period. About 43% of the children were boys. The median age was 6.8 years.

A total of 270 children were found to have irritable bowel syndrome. Fifteen of them also tested positive for serum IgA antitissue transglutaminase and endomysial antibodies, and all 15 also proved to have mucosal atrophy on duodenal biopsy specimens, which is indicative of celiac disease, said Dr. Fernanda Cristofori of the University of Bari (Italy) and Giovanni XXIII Hospital.

Thus, the prevalence of celiac disease was 4.4% in the children who had IBS. In comparison, the highest prevalence of celiac disease in any Italian population of children assessed to date was 1.1% in a study of 3,188 school children, the investigators said (JAMA Ped. 2014 April 21 [doi:10.1001/jamapediatrics.2013.4984]).

Clinicians should consider screening their IBS patients for celiac disease, given that 1 in 23 children with IBS in this series proved to have concomitant celiac disease. Failing to diagnose celiac disease in childhood increases the risk of complications such as osteopenia, short stature, delayed puberty, infertility, and intestinal lymphoma in late adulthood, Dr. Cristofori and her associates noted.

They reported no financial conflicts of interest.

BOSTON – Though progress is being made in reducing surgery for diverticulitis, one in three elective colectomies failed to meet current indications in a prospective study.

Among 1,102 patients in Washington state with an episode-based indication for elective surgery, the proportion with three or more prior episodes of diverticulitis increased from 42% in 2010 to 58% in 2012 (P = .007), while the proportion failing to meet either complication- or episode-based indications decreased from 41.3% to 29.6% (P = .002).

"Still, there remains a significant and persistent portion of cases being done in Washington that do not meet established guidelines," Dr. Vlad V. Simianu said at the annual meeting of the American Surgical Association.

The study involved 2,031 patients having elective resection for diverticulitis in 2010-2012 in 49 hospitals in Washington state’s voluntary Surgical Care and Outcomes Assessment Program (SCOAP), which captures about 80% of the surgical volume in the state. Their mean age was 58.8 years, 24% were younger than 50 years, and most were healthy, with only 27% having a Charlson Comorbidity Index score of 1 or more.

Patrice Wendling/Frontline Medical News

Washington has seen a dramatic threefold increase in elective colectomy for diverticulitis over the last 13 years, despite evolving recommendations, observed Dr. Simianu, a general surgery resident and research fellow at the University of Washington, Seattle. The 2006 American Society of Colon and Rectal Surgeons (ASCRS) guidelines, which were used for the study end points, said elective surgery can be safely delayed until three or more acute episodes of uncomplicated diverticulitis. The ASCRS just updated its guidelines again (Dis. Colon Rectum 2014;57:284-94) and now strongly recommend that the decision to proceed to elective colectomy after recovery from uncomplicated acute diverticulitis "be individualized."

Among all 2,031 patients in the study, a clinical indication for surgery was present in 23.3% (chronic fistula 10.5%, stricture 5.4%, bleeding 2.4%, and other 5%), while 55% of the 1,102 patients with an episode-based indication had three or more episodes.

In 2010, 22% of all patients had at least three prior episodes, 17% had chronic complications, and 23% had neither. This compares with 37.7%, 18%.6%, and 16.7% in 2012.

Possible explanations for the rise in guideline-concordant cases are that surgeons are documenting their indications more carefully or are delaying more operations until three or more acute episodes, Dr. Simianu said. Indeed, there was a significant decrease in the number of cases with missing indications in the clinical record over the study period (38% vs. 27%; P = .007).

The persistence of cases not meeting indications could be because the adoption of laparoscopy has lowered the threshold for surgeons to offer colectomy, similar to what has happened with laparoscopic cholecystectomy, he said. A laparoscopic operation was performed in 60% of the patients.

Other possible explanations are that the guidelines don’t capture all relevant indications, like persistent symptoms or pain, or that evolving evidence and guidelines are forcing some surgeons to wait before they change their practice, Dr. Simianu said.

"Nonetheless, we view this as an educational opportunity in our state to give feedback to surgeons in our network," he said.

Notably, the rate of elective and emergency resections per year did not increase significantly over the study period at 28 high-volume hospitals, performing at least 10 colectomies yearly. Data, however, were incomplete or missing, in 30.4% of cases.

Discussant Dr. Conor Delaney, chief of colorectal surgery at University Hospitals Case Medical Center, Cleveland, said it was good to see that the percentage of cases performed for three or more episodes rose across all age groups in the final year of the study, suggesting that the SCOAP intervention is likely working.

"It is still shocking to see 30 or 40% of cases being performed for fewer than three attacks," he said, adding that the 30% of patients who had surgery without appropriate indications "may really be, very much a best-case scenario."

He also asked whether the investigators could identify hospitals inside and outside SCOAP that were less likely to follow guidelines and how they dealt with patients who may have had appropriate single-attack surgery because of nonresolution of symptoms or inadequate drainage.

Dr. Simianu said it wasn’t possible to determine indications for hospitals outside the SCOAP network, but that participating hospitals followed a normal distribution. High-volume hospitals were "sort of middle of the road," while four or five low-volume hospitals were outliers and never or always met indications.

In response to the second query, he said their clinical indications included an "other" category that captured appropriate first-attack patients and that about 1% of surgery was performed for an abscess.

The next phase of research will be to go into surgeons’ offices to speak with surgeons and patients to try and quantify the missing indications, Dr. Simianu said.

Dr. Simianu reported funding from the National Institute of Diabetes and Digestive and Kidney Disease, the Agency for Healthcare Research & Quality, and Life Sciences Discovery Fund. Three co-authors reported serving as an advisor, consultant, or speaker for pharmaceutical and device firms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, Mass., is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Though progress is being made in reducing surgery for diverticulitis, one in three elective colectomies failed to meet current indications in a prospective study.

Among 1,102 patients in Washington state with an episode-based indication for elective surgery, the proportion with three or more prior episodes of diverticulitis increased from 42% in 2010 to 58% in 2012 (P = .007), while the proportion failing to meet either complication- or episode-based indications decreased from 41.3% to 29.6% (P = .002).

"Still, there remains a significant and persistent portion of cases being done in Washington that do not meet established guidelines," Dr. Vlad V. Simianu said at the annual meeting of the American Surgical Association.

The study involved 2,031 patients having elective resection for diverticulitis in 2010-2012 in 49 hospitals in Washington state’s voluntary Surgical Care and Outcomes Assessment Program (SCOAP), which captures about 80% of the surgical volume in the state. Their mean age was 58.8 years, 24% were younger than 50 years, and most were healthy, with only 27% having a Charlson Comorbidity Index score of 1 or more.

Patrice Wendling/Frontline Medical News

Washington has seen a dramatic threefold increase in elective colectomy for diverticulitis over the last 13 years, despite evolving recommendations, observed Dr. Simianu, a general surgery resident and research fellow at the University of Washington, Seattle. The 2006 American Society of Colon and Rectal Surgeons (ASCRS) guidelines, which were used for the study end points, said elective surgery can be safely delayed until three or more acute episodes of uncomplicated diverticulitis. The ASCRS just updated its guidelines again (Dis. Colon Rectum 2014;57:284-94) and now strongly recommend that the decision to proceed to elective colectomy after recovery from uncomplicated acute diverticulitis "be individualized."

Among all 2,031 patients in the study, a clinical indication for surgery was present in 23.3% (chronic fistula 10.5%, stricture 5.4%, bleeding 2.4%, and other 5%), while 55% of the 1,102 patients with an episode-based indication had three or more episodes.

In 2010, 22% of all patients had at least three prior episodes, 17% had chronic complications, and 23% had neither. This compares with 37.7%, 18%.6%, and 16.7% in 2012.

Possible explanations for the rise in guideline-concordant cases are that surgeons are documenting their indications more carefully or are delaying more operations until three or more acute episodes, Dr. Simianu said. Indeed, there was a significant decrease in the number of cases with missing indications in the clinical record over the study period (38% vs. 27%; P = .007).

The persistence of cases not meeting indications could be because the adoption of laparoscopy has lowered the threshold for surgeons to offer colectomy, similar to what has happened with laparoscopic cholecystectomy, he said. A laparoscopic operation was performed in 60% of the patients.

Other possible explanations are that the guidelines don’t capture all relevant indications, like persistent symptoms or pain, or that evolving evidence and guidelines are forcing some surgeons to wait before they change their practice, Dr. Simianu said.

"Nonetheless, we view this as an educational opportunity in our state to give feedback to surgeons in our network," he said.

Notably, the rate of elective and emergency resections per year did not increase significantly over the study period at 28 high-volume hospitals, performing at least 10 colectomies yearly. Data, however, were incomplete or missing, in 30.4% of cases.

Discussant Dr. Conor Delaney, chief of colorectal surgery at University Hospitals Case Medical Center, Cleveland, said it was good to see that the percentage of cases performed for three or more episodes rose across all age groups in the final year of the study, suggesting that the SCOAP intervention is likely working.

"It is still shocking to see 30 or 40% of cases being performed for fewer than three attacks," he said, adding that the 30% of patients who had surgery without appropriate indications "may really be, very much a best-case scenario."

He also asked whether the investigators could identify hospitals inside and outside SCOAP that were less likely to follow guidelines and how they dealt with patients who may have had appropriate single-attack surgery because of nonresolution of symptoms or inadequate drainage.

Dr. Simianu said it wasn’t possible to determine indications for hospitals outside the SCOAP network, but that participating hospitals followed a normal distribution. High-volume hospitals were "sort of middle of the road," while four or five low-volume hospitals were outliers and never or always met indications.

In response to the second query, he said their clinical indications included an "other" category that captured appropriate first-attack patients and that about 1% of surgery was performed for an abscess.

The next phase of research will be to go into surgeons’ offices to speak with surgeons and patients to try and quantify the missing indications, Dr. Simianu said.

Dr. Simianu reported funding from the National Institute of Diabetes and Digestive and Kidney Disease, the Agency for Healthcare Research & Quality, and Life Sciences Discovery Fund. Three co-authors reported serving as an advisor, consultant, or speaker for pharmaceutical and device firms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, Mass., is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – Though progress is being made in reducing surgery for diverticulitis, one in three elective colectomies failed to meet current indications in a prospective study.

Among 1,102 patients in Washington state with an episode-based indication for elective surgery, the proportion with three or more prior episodes of diverticulitis increased from 42% in 2010 to 58% in 2012 (P = .007), while the proportion failing to meet either complication- or episode-based indications decreased from 41.3% to 29.6% (P = .002).

"Still, there remains a significant and persistent portion of cases being done in Washington that do not meet established guidelines," Dr. Vlad V. Simianu said at the annual meeting of the American Surgical Association.

The study involved 2,031 patients having elective resection for diverticulitis in 2010-2012 in 49 hospitals in Washington state’s voluntary Surgical Care and Outcomes Assessment Program (SCOAP), which captures about 80% of the surgical volume in the state. Their mean age was 58.8 years, 24% were younger than 50 years, and most were healthy, with only 27% having a Charlson Comorbidity Index score of 1 or more.

Patrice Wendling/Frontline Medical News

Washington has seen a dramatic threefold increase in elective colectomy for diverticulitis over the last 13 years, despite evolving recommendations, observed Dr. Simianu, a general surgery resident and research fellow at the University of Washington, Seattle. The 2006 American Society of Colon and Rectal Surgeons (ASCRS) guidelines, which were used for the study end points, said elective surgery can be safely delayed until three or more acute episodes of uncomplicated diverticulitis. The ASCRS just updated its guidelines again (Dis. Colon Rectum 2014;57:284-94) and now strongly recommend that the decision to proceed to elective colectomy after recovery from uncomplicated acute diverticulitis "be individualized."

Among all 2,031 patients in the study, a clinical indication for surgery was present in 23.3% (chronic fistula 10.5%, stricture 5.4%, bleeding 2.4%, and other 5%), while 55% of the 1,102 patients with an episode-based indication had three or more episodes.

In 2010, 22% of all patients had at least three prior episodes, 17% had chronic complications, and 23% had neither. This compares with 37.7%, 18%.6%, and 16.7% in 2012.

Possible explanations for the rise in guideline-concordant cases are that surgeons are documenting their indications more carefully or are delaying more operations until three or more acute episodes, Dr. Simianu said. Indeed, there was a significant decrease in the number of cases with missing indications in the clinical record over the study period (38% vs. 27%; P = .007).

The persistence of cases not meeting indications could be because the adoption of laparoscopy has lowered the threshold for surgeons to offer colectomy, similar to what has happened with laparoscopic cholecystectomy, he said. A laparoscopic operation was performed in 60% of the patients.

Other possible explanations are that the guidelines don’t capture all relevant indications, like persistent symptoms or pain, or that evolving evidence and guidelines are forcing some surgeons to wait before they change their practice, Dr. Simianu said.

"Nonetheless, we view this as an educational opportunity in our state to give feedback to surgeons in our network," he said.

Notably, the rate of elective and emergency resections per year did not increase significantly over the study period at 28 high-volume hospitals, performing at least 10 colectomies yearly. Data, however, were incomplete or missing, in 30.4% of cases.

Discussant Dr. Conor Delaney, chief of colorectal surgery at University Hospitals Case Medical Center, Cleveland, said it was good to see that the percentage of cases performed for three or more episodes rose across all age groups in the final year of the study, suggesting that the SCOAP intervention is likely working.

"It is still shocking to see 30 or 40% of cases being performed for fewer than three attacks," he said, adding that the 30% of patients who had surgery without appropriate indications "may really be, very much a best-case scenario."

He also asked whether the investigators could identify hospitals inside and outside SCOAP that were less likely to follow guidelines and how they dealt with patients who may have had appropriate single-attack surgery because of nonresolution of symptoms or inadequate drainage.

Dr. Simianu said it wasn’t possible to determine indications for hospitals outside the SCOAP network, but that participating hospitals followed a normal distribution. High-volume hospitals were "sort of middle of the road," while four or five low-volume hospitals were outliers and never or always met indications.

In response to the second query, he said their clinical indications included an "other" category that captured appropriate first-attack patients and that about 1% of surgery was performed for an abscess.

The next phase of research will be to go into surgeons’ offices to speak with surgeons and patients to try and quantify the missing indications, Dr. Simianu said.

Dr. Simianu reported funding from the National Institute of Diabetes and Digestive and Kidney Disease, the Agency for Healthcare Research & Quality, and Life Sciences Discovery Fund. Three co-authors reported serving as an advisor, consultant, or speaker for pharmaceutical and device firms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th Annual Meeting, April 2014, in Boston, Mass., is anticipated to be published in the Annals of Surgery, pending editorial review.

pwendling@frontlinemedcom.com

BOSTON – The risks of readmission and emergency surgery are low for patients with acute diverticulitis initially managed nonoperatively, a population-based, competing risk analysis found.

At a median of 3.9 years (range, 1.7-6.4 years) after discharge among 14,124 patients, only 8% required urgent readmission. Of these, 22% went on to urgent surgery and 20%, to elective surgery after additional episodes.

Among the remaining 12,981 patients with no urgent readmissions, 9% went on to elective surgery, 13% died of other causes, and 78% had no events in follow-up, Dr. Debbie Li said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

The 5-year cumulative incidence was 9% for readmission, 1.9% for emergency surgery, and 14.1% for all-cause mortality.

"Elective colectomy may not be warranted for the majority of patients in the absence of chronic symptoms or multiple frequent recurrences," she said.

Elective colectomy has traditionally been recommended for patients at high risk for future recurrence and emergency surgery based on the indications of age less than 50 years, complicated disease including perforation and abscess, and two or more episodes of uncomplicated disease. Evidence is building, however, to challenge these indications, and guidelines are evolving, said Dr. Li, a general surgery resident at the University of Toronto.

The current study used administrative data to identify all patients in Ontario, Canada, treated nonoperatively at first hospitalization for diverticulitis from 2002 to 2012. Time-to-event and competing-risk regression analyses were performed, with data adjusted for such potential confounders as sex, medical comorbidity, neighborhood income quintile, rural residency, and calendar year of index admission.

Data are limited on the natural history of diverticulitis, and the few population-based studies that have been conducted have not accounted for competing risks such as elective colectomy or death, Dr. Li said.

The patients’ median age was 59 years, 79% had uncomplicated index disease, 18% had complicated disease (abscess, fistula, and perforation) with no abscess drain, and 3% had complicated disease with an abscess drain.

Young patients had more readmissions than those 50 years and older (10.5% vs. 8.4%; P less than .001), but not more emergency surgery (1.8% vs. 2.0%; P = .52), she said.

For patients older than 50 years, the risk of death by other causes was 10 times the risk of an emergency surgery for diverticulitis (19.5% vs. 2%).

Patients with complicated rather than uncomplicated index disease had more readmissions (12% vs. 8.2%; P less than .001) and urgent surgery (4.3% vs. 1.4%; P less than .001).

In adjusted analyses, young age was associated with more readmissions (hazard ratio, 1.24), but not subsequent emergency surgery (HR, 0.83). Complicated disease (HR, 3.15) and multiple recurrences (HR, 2.41) predicted an increased risk for emergency surgery.

"Young age, complicated disease, and multiple recurrences do infer increased relative risk, but the vast majority (85%) of such patients remain recurrence free," Dr. Li said.

Invited discussant Dr. David Schoetz, professor of surgery, Tufts University, Boston, said, "While it’s reassuring that even complicated diverticulitis can be safely managed without subsequent operation, there still must be a subgroup who should be offered early surgery."

With disease severity more common in younger patients and overall mortality less than 1%, perhaps aggressive surgery would be justified in those younger than 50 years, he suggested.

Dr. Li responded that an administrative database is unable to capture clinical nuances such as which patients had ongoing symptoms, chronic persistent disease, or reduced quality of life, and that a prospective trial would be needed to identify which subgroup of patients will need aggressive surgery.

Older patients, those with more complicated disease, and those with greater medical comorbidities are more likely to undergo urgent surgery, according to ongoing analyses of roughly 4,000 patients, treated during the same time period, but excluded from the current analysis because they underwent surgery at index admission. Previously published work also suggests that patients with a higher body mass index have poorer outcomes.

A recent systematic review of diverticulitis surgery (JAMA Surg. 2014;149:292-303) reported that complicated recurrence after an episode of uncomplicated diverticulitis is rare, occurring in less than 5% of cases. The authors called for existing guidelines to be updated and said that decisions to proceed with elective surgery should be based instead on patient-reported frequency and severity of symptoms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Li and her coauthors reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

BOSTON – The risks of readmission and emergency surgery are low for patients with acute diverticulitis initially managed nonoperatively, a population-based, competing risk analysis found.

At a median of 3.9 years (range, 1.7-6.4 years) after discharge among 14,124 patients, only 8% required urgent readmission. Of these, 22% went on to urgent surgery and 20%, to elective surgery after additional episodes.

Among the remaining 12,981 patients with no urgent readmissions, 9% went on to elective surgery, 13% died of other causes, and 78% had no events in follow-up, Dr. Debbie Li said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

The 5-year cumulative incidence was 9% for readmission, 1.9% for emergency surgery, and 14.1% for all-cause mortality.

"Elective colectomy may not be warranted for the majority of patients in the absence of chronic symptoms or multiple frequent recurrences," she said.

Elective colectomy has traditionally been recommended for patients at high risk for future recurrence and emergency surgery based on the indications of age less than 50 years, complicated disease including perforation and abscess, and two or more episodes of uncomplicated disease. Evidence is building, however, to challenge these indications, and guidelines are evolving, said Dr. Li, a general surgery resident at the University of Toronto.

The current study used administrative data to identify all patients in Ontario, Canada, treated nonoperatively at first hospitalization for diverticulitis from 2002 to 2012. Time-to-event and competing-risk regression analyses were performed, with data adjusted for such potential confounders as sex, medical comorbidity, neighborhood income quintile, rural residency, and calendar year of index admission.

Data are limited on the natural history of diverticulitis, and the few population-based studies that have been conducted have not accounted for competing risks such as elective colectomy or death, Dr. Li said.

The patients’ median age was 59 years, 79% had uncomplicated index disease, 18% had complicated disease (abscess, fistula, and perforation) with no abscess drain, and 3% had complicated disease with an abscess drain.

Young patients had more readmissions than those 50 years and older (10.5% vs. 8.4%; P less than .001), but not more emergency surgery (1.8% vs. 2.0%; P = .52), she said.

For patients older than 50 years, the risk of death by other causes was 10 times the risk of an emergency surgery for diverticulitis (19.5% vs. 2%).

Patients with complicated rather than uncomplicated index disease had more readmissions (12% vs. 8.2%; P less than .001) and urgent surgery (4.3% vs. 1.4%; P less than .001).

In adjusted analyses, young age was associated with more readmissions (hazard ratio, 1.24), but not subsequent emergency surgery (HR, 0.83). Complicated disease (HR, 3.15) and multiple recurrences (HR, 2.41) predicted an increased risk for emergency surgery.

"Young age, complicated disease, and multiple recurrences do infer increased relative risk, but the vast majority (85%) of such patients remain recurrence free," Dr. Li said.

Invited discussant Dr. David Schoetz, professor of surgery, Tufts University, Boston, said, "While it’s reassuring that even complicated diverticulitis can be safely managed without subsequent operation, there still must be a subgroup who should be offered early surgery."

With disease severity more common in younger patients and overall mortality less than 1%, perhaps aggressive surgery would be justified in those younger than 50 years, he suggested.

Dr. Li responded that an administrative database is unable to capture clinical nuances such as which patients had ongoing symptoms, chronic persistent disease, or reduced quality of life, and that a prospective trial would be needed to identify which subgroup of patients will need aggressive surgery.

Older patients, those with more complicated disease, and those with greater medical comorbidities are more likely to undergo urgent surgery, according to ongoing analyses of roughly 4,000 patients, treated during the same time period, but excluded from the current analysis because they underwent surgery at index admission. Previously published work also suggests that patients with a higher body mass index have poorer outcomes.

A recent systematic review of diverticulitis surgery (JAMA Surg. 2014;149:292-303) reported that complicated recurrence after an episode of uncomplicated diverticulitis is rare, occurring in less than 5% of cases. The authors called for existing guidelines to be updated and said that decisions to proceed with elective surgery should be based instead on patient-reported frequency and severity of symptoms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Li and her coauthors reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

BOSTON – The risks of readmission and emergency surgery are low for patients with acute diverticulitis initially managed nonoperatively, a population-based, competing risk analysis found.

At a median of 3.9 years (range, 1.7-6.4 years) after discharge among 14,124 patients, only 8% required urgent readmission. Of these, 22% went on to urgent surgery and 20%, to elective surgery after additional episodes.

Among the remaining 12,981 patients with no urgent readmissions, 9% went on to elective surgery, 13% died of other causes, and 78% had no events in follow-up, Dr. Debbie Li said at the annual meeting of the American Surgical Association.

Patrice Wendling/Frontline Medical News

The 5-year cumulative incidence was 9% for readmission, 1.9% for emergency surgery, and 14.1% for all-cause mortality.

"Elective colectomy may not be warranted for the majority of patients in the absence of chronic symptoms or multiple frequent recurrences," she said.

Elective colectomy has traditionally been recommended for patients at high risk for future recurrence and emergency surgery based on the indications of age less than 50 years, complicated disease including perforation and abscess, and two or more episodes of uncomplicated disease. Evidence is building, however, to challenge these indications, and guidelines are evolving, said Dr. Li, a general surgery resident at the University of Toronto.

The current study used administrative data to identify all patients in Ontario, Canada, treated nonoperatively at first hospitalization for diverticulitis from 2002 to 2012. Time-to-event and competing-risk regression analyses were performed, with data adjusted for such potential confounders as sex, medical comorbidity, neighborhood income quintile, rural residency, and calendar year of index admission.

Data are limited on the natural history of diverticulitis, and the few population-based studies that have been conducted have not accounted for competing risks such as elective colectomy or death, Dr. Li said.

The patients’ median age was 59 years, 79% had uncomplicated index disease, 18% had complicated disease (abscess, fistula, and perforation) with no abscess drain, and 3% had complicated disease with an abscess drain.

Young patients had more readmissions than those 50 years and older (10.5% vs. 8.4%; P less than .001), but not more emergency surgery (1.8% vs. 2.0%; P = .52), she said.

For patients older than 50 years, the risk of death by other causes was 10 times the risk of an emergency surgery for diverticulitis (19.5% vs. 2%).

Patients with complicated rather than uncomplicated index disease had more readmissions (12% vs. 8.2%; P less than .001) and urgent surgery (4.3% vs. 1.4%; P less than .001).

In adjusted analyses, young age was associated with more readmissions (hazard ratio, 1.24), but not subsequent emergency surgery (HR, 0.83). Complicated disease (HR, 3.15) and multiple recurrences (HR, 2.41) predicted an increased risk for emergency surgery.

"Young age, complicated disease, and multiple recurrences do infer increased relative risk, but the vast majority (85%) of such patients remain recurrence free," Dr. Li said.

Invited discussant Dr. David Schoetz, professor of surgery, Tufts University, Boston, said, "While it’s reassuring that even complicated diverticulitis can be safely managed without subsequent operation, there still must be a subgroup who should be offered early surgery."

With disease severity more common in younger patients and overall mortality less than 1%, perhaps aggressive surgery would be justified in those younger than 50 years, he suggested.

Dr. Li responded that an administrative database is unable to capture clinical nuances such as which patients had ongoing symptoms, chronic persistent disease, or reduced quality of life, and that a prospective trial would be needed to identify which subgroup of patients will need aggressive surgery.

Older patients, those with more complicated disease, and those with greater medical comorbidities are more likely to undergo urgent surgery, according to ongoing analyses of roughly 4,000 patients, treated during the same time period, but excluded from the current analysis because they underwent surgery at index admission. Previously published work also suggests that patients with a higher body mass index have poorer outcomes.

A recent systematic review of diverticulitis surgery (JAMA Surg. 2014;149:292-303) reported that complicated recurrence after an episode of uncomplicated diverticulitis is rare, occurring in less than 5% of cases. The authors called for existing guidelines to be updated and said that decisions to proceed with elective surgery should be based instead on patient-reported frequency and severity of symptoms.

The complete manuscript of this study and its presentation at the American Surgical Association’s 134th annual meeting, April 2014, in Boston, is anticipated to be published in the Annals of Surgery, pending editorial review.

Dr. Li and her coauthors reported no relevant financial disclosures.

pwendling@frontlinemedcom.com

Clonidine was not better than placebo for fecal incontinence despite previous reports to the contrary.

The finding, reported in the May issue of Clinical Gastroenterology and Hepatology (doi:10.1016/j.cgh.2013.06.035), gives further weight to a 2010 Cochrane review, which concluded that there was "limited evidence to guide clinicians in the selection of drug therapies for fecal incontinence," wrote Dr. Adil E. Bharucha and his colleagues. Clonidine, a centrally acting adrenergic agent, is approved to treat high blood pressure and is sometimes used to treat attention-deficit/hyperactivity disorder, dysmenorrhea, and Tourette’s syndrome.

In a placebo-controlled, double-blind study of 44 women with fecal incontinence, Dr. Bharucha of the Mayo Clinic, in Rochester, Minn., randomized 22 subjects to 0.1 mg oral clonidine twice daily or placebo.

For inclusion in the study, all subjects had to have taken the Fecal Incontinence and Continence Assessment (FICA) and reported that they were "often" or "usually" incontinent because they had "great urgency and could not reach the toilet on time."

Patients with current or prior organic colonic or anorectal diseases, including rectal cancer, were excluded, as were patients with neurologic disorders including spinal cord injury and Parkinson’s disease.

Initially, all participants underwent 4 weeks without treatment, recording their bowel habits, to establish a baseline.

That was then followed by 4 weeks of treatment with either placebo or clonidine 0.1 mg twice daily.

Patients also underwent anorectal sensorimotor function assessment at the conclusion of both the baseline period and the 4-week study period.

Dr. Bharucha found that both placebo and clonidine patients experienced an overall reduction in the number of days with at least one episode of fecal incontinence during the treatment period.

Indeed, placebo patients reported a decrease from 16 days with at least one incontinence episode during the baseline recording phase to 11 days during treatment, while clonidine patients reported a drop from 13 days during baseline to 8 days while on the drug, a difference that was not significant.

Both groups also reported a similar drop in the mean weekly FICA symptom severity score, from 9.1 to 7.6 for placebo patients and from 8.1 to 6.5 in the treatment group.

Finally, a total of eight placebo patients and seven clonidine patients reported a 50% or greater reduction in the number of days with fecal incontinence.

Looking at anorectal function, Dr. Bharucha found that the drug did not significantly affect anal resting or squeeze pressures, rectal capacity, compliance, or sensation assessed by sensory thresholds, or visual analog scale scores during rectal distention, compared with baseline measurements.

Further, "Correlations of changes during treatment in symptoms (that is, number of days and episodes of fecal incontinence, rectal urgency, and stool consistency) separately with rectal compliance and capacity and sensory thresholds were not significant," they added.

Meanwhile, looking at adverse effects, the overall incidence was significantly higher among clonidine patients, who especially reported dry mouth.

"In our prior uncontrolled study (Aliment. Pharmacol. Ther. 2010;32:681-8) with a similar dose (0.2 mg/d) of transdermal clonidine, overall effects on anorectal functions were not significant," the authors wrote.

However, that study did find that symptom relief was correlated with effects on rectal compliance and sensation in a dose-dependent manner, leading the authors to speculate that the failure of the current study might be due to inadequate dosing.

The authors stated that they had no conflicts of interest to disclose. They added that the study was supported by the National Institutes of Health.

Clonidine was not better than placebo for fecal incontinence despite previous reports to the contrary.

The finding, reported in the May issue of Clinical Gastroenterology and Hepatology (doi:10.1016/j.cgh.2013.06.035), gives further weight to a 2010 Cochrane review, which concluded that there was "limited evidence to guide clinicians in the selection of drug therapies for fecal incontinence," wrote Dr. Adil E. Bharucha and his colleagues. Clonidine, a centrally acting adrenergic agent, is approved to treat high blood pressure and is sometimes used to treat attention-deficit/hyperactivity disorder, dysmenorrhea, and Tourette’s syndrome.

In a placebo-controlled, double-blind study of 44 women with fecal incontinence, Dr. Bharucha of the Mayo Clinic, in Rochester, Minn., randomized 22 subjects to 0.1 mg oral clonidine twice daily or placebo.

For inclusion in the study, all subjects had to have taken the Fecal Incontinence and Continence Assessment (FICA) and reported that they were "often" or "usually" incontinent because they had "great urgency and could not reach the toilet on time."

Patients with current or prior organic colonic or anorectal diseases, including rectal cancer, were excluded, as were patients with neurologic disorders including spinal cord injury and Parkinson’s disease.

Initially, all participants underwent 4 weeks without treatment, recording their bowel habits, to establish a baseline.

That was then followed by 4 weeks of treatment with either placebo or clonidine 0.1 mg twice daily.

Patients also underwent anorectal sensorimotor function assessment at the conclusion of both the baseline period and the 4-week study period.

Dr. Bharucha found that both placebo and clonidine patients experienced an overall reduction in the number of days with at least one episode of fecal incontinence during the treatment period.

Indeed, placebo patients reported a decrease from 16 days with at least one incontinence episode during the baseline recording phase to 11 days during treatment, while clonidine patients reported a drop from 13 days during baseline to 8 days while on the drug, a difference that was not significant.

Both groups also reported a similar drop in the mean weekly FICA symptom severity score, from 9.1 to 7.6 for placebo patients and from 8.1 to 6.5 in the treatment group.

Finally, a total of eight placebo patients and seven clonidine patients reported a 50% or greater reduction in the number of days with fecal incontinence.

Looking at anorectal function, Dr. Bharucha found that the drug did not significantly affect anal resting or squeeze pressures, rectal capacity, compliance, or sensation assessed by sensory thresholds, or visual analog scale scores during rectal distention, compared with baseline measurements.

Further, "Correlations of changes during treatment in symptoms (that is, number of days and episodes of fecal incontinence, rectal urgency, and stool consistency) separately with rectal compliance and capacity and sensory thresholds were not significant," they added.

Meanwhile, looking at adverse effects, the overall incidence was significantly higher among clonidine patients, who especially reported dry mouth.

"In our prior uncontrolled study (Aliment. Pharmacol. Ther. 2010;32:681-8) with a similar dose (0.2 mg/d) of transdermal clonidine, overall effects on anorectal functions were not significant," the authors wrote.

However, that study did find that symptom relief was correlated with effects on rectal compliance and sensation in a dose-dependent manner, leading the authors to speculate that the failure of the current study might be due to inadequate dosing.

The authors stated that they had no conflicts of interest to disclose. They added that the study was supported by the National Institutes of Health.

Clonidine was not better than placebo for fecal incontinence despite previous reports to the contrary.

The finding, reported in the May issue of Clinical Gastroenterology and Hepatology (doi:10.1016/j.cgh.2013.06.035), gives further weight to a 2010 Cochrane review, which concluded that there was "limited evidence to guide clinicians in the selection of drug therapies for fecal incontinence," wrote Dr. Adil E. Bharucha and his colleagues. Clonidine, a centrally acting adrenergic agent, is approved to treat high blood pressure and is sometimes used to treat attention-deficit/hyperactivity disorder, dysmenorrhea, and Tourette’s syndrome.

In a placebo-controlled, double-blind study of 44 women with fecal incontinence, Dr. Bharucha of the Mayo Clinic, in Rochester, Minn., randomized 22 subjects to 0.1 mg oral clonidine twice daily or placebo.

For inclusion in the study, all subjects had to have taken the Fecal Incontinence and Continence Assessment (FICA) and reported that they were "often" or "usually" incontinent because they had "great urgency and could not reach the toilet on time."

Patients with current or prior organic colonic or anorectal diseases, including rectal cancer, were excluded, as were patients with neurologic disorders including spinal cord injury and Parkinson’s disease.

Initially, all participants underwent 4 weeks without treatment, recording their bowel habits, to establish a baseline.

That was then followed by 4 weeks of treatment with either placebo or clonidine 0.1 mg twice daily.

Patients also underwent anorectal sensorimotor function assessment at the conclusion of both the baseline period and the 4-week study period.

Dr. Bharucha found that both placebo and clonidine patients experienced an overall reduction in the number of days with at least one episode of fecal incontinence during the treatment period.

Indeed, placebo patients reported a decrease from 16 days with at least one incontinence episode during the baseline recording phase to 11 days during treatment, while clonidine patients reported a drop from 13 days during baseline to 8 days while on the drug, a difference that was not significant.

Both groups also reported a similar drop in the mean weekly FICA symptom severity score, from 9.1 to 7.6 for placebo patients and from 8.1 to 6.5 in the treatment group.

Finally, a total of eight placebo patients and seven clonidine patients reported a 50% or greater reduction in the number of days with fecal incontinence.

Looking at anorectal function, Dr. Bharucha found that the drug did not significantly affect anal resting or squeeze pressures, rectal capacity, compliance, or sensation assessed by sensory thresholds, or visual analog scale scores during rectal distention, compared with baseline measurements.

Further, "Correlations of changes during treatment in symptoms (that is, number of days and episodes of fecal incontinence, rectal urgency, and stool consistency) separately with rectal compliance and capacity and sensory thresholds were not significant," they added.

Meanwhile, looking at adverse effects, the overall incidence was significantly higher among clonidine patients, who especially reported dry mouth.

"In our prior uncontrolled study (Aliment. Pharmacol. Ther. 2010;32:681-8) with a similar dose (0.2 mg/d) of transdermal clonidine, overall effects on anorectal functions were not significant," the authors wrote.

However, that study did find that symptom relief was correlated with effects on rectal compliance and sensation in a dose-dependent manner, leading the authors to speculate that the failure of the current study might be due to inadequate dosing.

The authors stated that they had no conflicts of interest to disclose. They added that the study was supported by the National Institutes of Health.

Experts have signaled a need for the development of validated patient-reported outcomes for inflammatory bowel disease based on Food and Drug Administration guidance, in the face of a move toward the use of patient-reported outcomes and objective measures of disease as the primary endpoint for clinical trials.

Dr. Nicolas Williet, from the Université Henri Poincaré, Vandoeuvre-lès-Nancy, France, and his colleagues wrote that the FDA was moving away from use of the Crohn’s Disease Activity Index in the assessment of inflammatory bowel disease (IBD) outcomes, and would likely soon require patient-reported outcomes as a coprimary endpoint with objective measures such as endoscopic assessment.

Patient-reported outcomes should be obtained by using a validated, self-administered questionnaire with items that are generated solely by patients, the authors wrote online Feb. 19 in Clinical Gastroenterology and Hepatology.

"A PRO [patient-reported outcome] is any report that comes directly from a patient about a health condition or its treatment without interpretation of the patient’ s response by a clinician or anyone else," they wrote. "The items measured by PRO instruments that are used most often in support of labeling claims refer to a patient symptom, sign, or an aspect of functioning directly related to disease status."

However, the authors said that no existing patient-reported outcomes for IBD, such as the Inflammatory Bowel Disease Questionnaire assessing quality of life and the IBD Disability Index, were developed according to the recently developed FDA guidelines. There is a need for international consensus to develop validated patient-reported outcomes using FDA guidance, they asserted.

"During the development of PROs, the disease characteristics of the patients (type of IBD, extent of the disease, the presence or absence of objectively measured inflammation, presence or absence of disease complications such as stricture, fistula, and abscess, and so forth) must be documented carefully to determine the impact of various disease characteristics on the operating characteristics of the PRO."

Particularly in irritable bowel syndrome, there is still debate about how best to measure patient-reported outcomes, the authors said (Clin. Gastroenterol. Hepatol. 2014 Feb. 19 [doi: 10.1016/j.cgh.2014.02.016]).

"Depending on their structure and format, PROs can have different levels of sensitivity to core IBS symptoms and can be influenced by psychological and somatic complaints."

Patient-reported outcomes are already used in other chronic conditions such as rheumatoid arthritis and multiple sclerosis, with studies showing that patient-reported outcomes offer important endpoints for drug approval in these conditions.

"In the near future, PROs may evolve to be used as the primary or major secondary endpoints in clinical trials in patients with IBD, possibly leading to drug approval and labeling, similar to the JAK inhibitor in the treatment of myelofibrosis," the authors reported.

Two of the three authors disclosed consulting and lecture fees, as well as research support, from numerous pharmaceutical companies.

Experts have signaled a need for the development of validated patient-reported outcomes for inflammatory bowel disease based on Food and Drug Administration guidance, in the face of a move toward the use of patient-reported outcomes and objective measures of disease as the primary endpoint for clinical trials.

Dr. Nicolas Williet, from the Université Henri Poincaré, Vandoeuvre-lès-Nancy, France, and his colleagues wrote that the FDA was moving away from use of the Crohn’s Disease Activity Index in the assessment of inflammatory bowel disease (IBD) outcomes, and would likely soon require patient-reported outcomes as a coprimary endpoint with objective measures such as endoscopic assessment.

Patient-reported outcomes should be obtained by using a validated, self-administered questionnaire with items that are generated solely by patients, the authors wrote online Feb. 19 in Clinical Gastroenterology and Hepatology.

"A PRO [patient-reported outcome] is any report that comes directly from a patient about a health condition or its treatment without interpretation of the patient’ s response by a clinician or anyone else," they wrote. "The items measured by PRO instruments that are used most often in support of labeling claims refer to a patient symptom, sign, or an aspect of functioning directly related to disease status."

However, the authors said that no existing patient-reported outcomes for IBD, such as the Inflammatory Bowel Disease Questionnaire assessing quality of life and the IBD Disability Index, were developed according to the recently developed FDA guidelines. There is a need for international consensus to develop validated patient-reported outcomes using FDA guidance, they asserted.

"During the development of PROs, the disease characteristics of the patients (type of IBD, extent of the disease, the presence or absence of objectively measured inflammation, presence or absence of disease complications such as stricture, fistula, and abscess, and so forth) must be documented carefully to determine the impact of various disease characteristics on the operating characteristics of the PRO."

Particularly in irritable bowel syndrome, there is still debate about how best to measure patient-reported outcomes, the authors said (Clin. Gastroenterol. Hepatol. 2014 Feb. 19 [doi: 10.1016/j.cgh.2014.02.016]).

"Depending on their structure and format, PROs can have different levels of sensitivity to core IBS symptoms and can be influenced by psychological and somatic complaints."

Patient-reported outcomes are already used in other chronic conditions such as rheumatoid arthritis and multiple sclerosis, with studies showing that patient-reported outcomes offer important endpoints for drug approval in these conditions.

"In the near future, PROs may evolve to be used as the primary or major secondary endpoints in clinical trials in patients with IBD, possibly leading to drug approval and labeling, similar to the JAK inhibitor in the treatment of myelofibrosis," the authors reported.

Two of the three authors disclosed consulting and lecture fees, as well as research support, from numerous pharmaceutical companies.

Experts have signaled a need for the development of validated patient-reported outcomes for inflammatory bowel disease based on Food and Drug Administration guidance, in the face of a move toward the use of patient-reported outcomes and objective measures of disease as the primary endpoint for clinical trials.

Dr. Nicolas Williet, from the Université Henri Poincaré, Vandoeuvre-lès-Nancy, France, and his colleagues wrote that the FDA was moving away from use of the Crohn’s Disease Activity Index in the assessment of inflammatory bowel disease (IBD) outcomes, and would likely soon require patient-reported outcomes as a coprimary endpoint with objective measures such as endoscopic assessment.

Patient-reported outcomes should be obtained by using a validated, self-administered questionnaire with items that are generated solely by patients, the authors wrote online Feb. 19 in Clinical Gastroenterology and Hepatology.

"A PRO [patient-reported outcome] is any report that comes directly from a patient about a health condition or its treatment without interpretation of the patient’ s response by a clinician or anyone else," they wrote. "The items measured by PRO instruments that are used most often in support of labeling claims refer to a patient symptom, sign, or an aspect of functioning directly related to disease status."

However, the authors said that no existing patient-reported outcomes for IBD, such as the Inflammatory Bowel Disease Questionnaire assessing quality of life and the IBD Disability Index, were developed according to the recently developed FDA guidelines. There is a need for international consensus to develop validated patient-reported outcomes using FDA guidance, they asserted.

"During the development of PROs, the disease characteristics of the patients (type of IBD, extent of the disease, the presence or absence of objectively measured inflammation, presence or absence of disease complications such as stricture, fistula, and abscess, and so forth) must be documented carefully to determine the impact of various disease characteristics on the operating characteristics of the PRO."

Particularly in irritable bowel syndrome, there is still debate about how best to measure patient-reported outcomes, the authors said (Clin. Gastroenterol. Hepatol. 2014 Feb. 19 [doi: 10.1016/j.cgh.2014.02.016]).

"Depending on their structure and format, PROs can have different levels of sensitivity to core IBS symptoms and can be influenced by psychological and somatic complaints."

Patient-reported outcomes are already used in other chronic conditions such as rheumatoid arthritis and multiple sclerosis, with studies showing that patient-reported outcomes offer important endpoints for drug approval in these conditions.

"In the near future, PROs may evolve to be used as the primary or major secondary endpoints in clinical trials in patients with IBD, possibly leading to drug approval and labeling, similar to the JAK inhibitor in the treatment of myelofibrosis," the authors reported.

Two of the three authors disclosed consulting and lecture fees, as well as research support, from numerous pharmaceutical companies.